A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
NCT ID: NCT03184870
Last Updated: 2025-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
332 participants
INTERVENTIONAL
2017-08-08
2023-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
FOLFIRI: FOL (folinic acid \[leucovorin\]) F (fluorouracil \[5-fluorouracil\]) IRI (irinotecan \[CAMPTOSAR\])
BMS-813160
Specified dose on specified days
5-fluorouracil (5-FU)
Specified dose on specified days
Leucovorin
Specified dose on specified days
Irinotecan
Specified dose on specified days
Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
BMS-813160
Specified dose on specified days
Nab-paclitaxel
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable
BMS-813160
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
BMS-813160
Specified dose on specified days
5-fluorouracil (5-FU)
Specified dose on specified days
Leucovorin
Specified dose on specified days
Irinotecan
Specified dose on specified days
Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
BMS-813160
Specified dose on specified days
5-fluorouracil (5-FU)
Specified dose on specified days
Leucovorin
Specified dose on specified days
Irinotecan
Specified dose on specified days
Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI
5-fluorouracil (5-FU)
Specified dose on specified days
Leucovorin
Specified dose on specified days
Irinotecan
Specified dose on specified days
Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel
BMS-813160
Specified dose on specified days
Nab-paclitaxel
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
BMS-813160
Specified dose on specified days
Nivolumab
Specified dose on specified days
Nab-paclitaxel
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel
Nab-paclitaxel
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab
BMS-813160
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab
BMS-813160
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy
BMS-813160
Specified dose on specified days
Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy
BMS-813160
Specified dose on specified days
Interventions
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BMS-813160
Specified dose on specified days
Nivolumab
Specified dose on specified days
Nab-paclitaxel
Specified dose on specified days
Gemcitabine
Specified dose on specified days
5-fluorouracil (5-FU)
Specified dose on specified days
Leucovorin
Specified dose on specified days
Irinotecan
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
* Ability to swallow pills or capsules
* Required to undergo mandatory pre and on-treatment biopsies
* Adequate marrow function
* Adequate other organ functions
* Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up
Exclusion Criteria
* Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
* Active, known or suspected autoimmune disease
* Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
* Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor (PD-1), programmed death-ligand 1 \[PD(L)-1\] or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies
* History of allergy to study treatments or any of its components of the study arm that participant is enrolling
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0003
Birmingham, Alabama, United States
Local Institution - 0026
Phoenix, Arizona, United States
Local Institution - 0002
Los Angeles, California, United States
Local Institution - 0025
Los Angeles, California, United States
Local Institution - 0041
Orange, California, United States
Local Institution - 0015
Aurora, Colorado, United States
Local Institution - 0018
Washington D.C., District of Columbia, United States
Local Institution - 0048
Brooksville, Florida, United States
Local Institution - 0047
St. Petersburg, Florida, United States
Local Institution - 0005
Baltimore, Maryland, United States
Local Institution - 0033
Boston, Massachusetts, United States
Local Institution - 0027
Rochester, Minnesota, United States
Local Institution - 0039
Hattiesburg, Mississippi, United States
Local Institution - 0023
St Louis, Missouri, United States
Local Institution - 0004
Hackensack, New Jersey, United States
Local Institution - 0017
New York, New York, United States
Local Institution - 0024
Rochester, New York, United States
Local Institution - 0046
Charlotte, North Carolina, United States
Local Institution - 0044
Cleveland, Ohio, United States
Local Institution - 0021
Cleveland, Ohio, United States
Local Institution - 0037
Allentown, Pennsylvania, United States
Local Institution - 0014
Philadelphia, Pennsylvania, United States
Local Institution - 0020
Philadelphia, Pennsylvania, United States
Local Institution - 0045
Charleston, South Carolina, United States
Local Institution - 0034
Nashville, Tennessee, United States
Local Institution - 0038
Nashville, Tennessee, United States
Local Institution - 0016
Salt Lake City, Utah, United States
Local Institution - 0042
Charlottesville, Virginia, United States
Local Institution - 0028
Clayton, Victoria, Australia
Local Institution - 0050
Brussels, , Belgium
Local Institution - 0051
Edegem, , Belgium
Local Institution - 0049
Leuven, , Belgium
Local Institution - 0013
Edmonton, Alberta, Canada
Local Institution - 0012
Ottawa, Ontario, Canada
Local Institution - 0001
Toronto, Ontario, Canada
Local Institution - 0022
Dresden, , Germany
Local Institution - 0007
Heidelberg, , Germany
Local Institution - 0031
Barcelona, , Spain
Local Institution - 0032
Madrid, , Spain
Local Institution - 0030
Majadahonda - Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2017-001725-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV202-103
Identifier Type: -
Identifier Source: org_study_id
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